In the open-label trial, 222 patients with completely resected disease from 27 sites in China were randomized between September 2011 and April 2014 to receive gefitinib at 250 mg once daily for 24 months (n = 11) or vinorelbine at 25 mg/m² on days 1 and 8 plus cisplatin at 75 mg/m² on day 1 every 3 weeks for 4 cycles (n = 111). The primary endpoint was disease-free survival in the intention-to-treat population.

Disease-Free Survival

The median follow-up was 36.5 months. The median disease-free survival was 28.7 months in the gefitinib group vs 18.0 months in the vinorelbine/cisplatin group (hazard ratio [HR] = 0.60, P = .0054). Three-year disease-free survival was 34% vs 27% (P = .37). Overall survival data were not mature at the time of this analysis.

The gefitinib group had a significant improvement from baseline at week 33 vs the chemotherapy group in the Trial Outcome Index of the Functional Assessment of Cancer Therapy–Lung Cancer questionnaire (P = .012).

The investigators concluded: “Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited, and overall survival data are not yet mature.”

The study was funded by the Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine, the National Health and Family Planning Commission of the People’s Republic of China, the Guangzhou Science and Technology Bureau, and AstraZeneca China.

Yi-Long Wu, MD, of the Guangdong General Hospital, Guangdong Academy of Medical Science, is the corresponding author of The Lancet Oncology article.

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